Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission

NCT ID: NCT02412085

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-01-31

Brief Summary

This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.

At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.

Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Golimumab

Subcutaneous golimumab

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2)

Maintenance regimen:

• body weight < 80kg: 50 mg every 4 weeks
• body weight ≥ 80 kg: 100 mg every 4 weeks

Interventions

Golimumab

Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2)

Maintenance regimen:

• body weight < 80kg: 50 mg every 4 weeks
• body weight ≥ 80 kg: 100 mg every 4 weeks

Intervention Type: DRUG

Other Intervention Names

Simponi

Eligibility Criteria

Inclusion Criteria

• patients aged 18-65 years
• ability to understand the study procedures and sign the informed consent
• ulcerative colitis diagnosed at least 6 months before
• no previous exposure to anti-TNFs
• Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
• steroid-dependent disease
• women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation

Exclusion Criteria

• Crohn's disease or undetermined colitis
• active infections or previous infections not completely resolved at baseline
• malignancies in the previous 5 years
• suspected latent tuberculosis infection
• every other potentially harmful clinical condition, in the opinion of the investigator
• patients with moderately to severe heart failure (NYHA class III/IV)
• hepatic or renal failure
• pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
• not permitted concomitant medications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvio Danese, MD, PhD

Role: STUDY_CHAIR

IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY

Locations

IBD Center

Rozzano, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvio Danese, MD, PhD

Role: CONTACT

sdanese@hotmail.com

0039028224 ext. 5555

Gionata Fiorino, MD, PhD

Role: CONTACT

gionata.fiorino@humanitas.it

0038028224 ext. 5555

Facility Contacts

Silvio Danese, MD, PhD

Role: primary

sdanese@hotmail.com

0039028224 ext. 5555

Other Identifiers

1371

Identifier Type: -

Identifier Source: org_study_id